DESLORATADINE GEDEON RICHTER 5 MG FILM-COATED TABLETS

Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

Desloratadine 5mg
film-coated tablets
desloratadine
Read all of this leaflet carefully before you start taking this medicine.
− Keep this leaﬂet. You may need to read it again.
− If you have any further questions, ask your doctor or pharmacist.
− This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
− If any of the side eﬀects gets serious, or if you notice any side eﬀects not listed in this leaﬂet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Desloratadine is and what it is used for
2. Before you take Desloratadine
3. How to take Desloratadine
4. Possible side eﬀects
5. How to store Desloratadine
6. Further information

1. WHAT DESLORATADINE IS AND
WHAT IT IS USED FOR
Desloratadine is an antiallergy medicine that does not
make you drowsy. It helps control your allergic reaction
and its symptoms.
Desloratadine relieves symptoms associated with
allergic rhinitis (inﬂammation of the nasal passages
caused by an allergy, for example, hay fever or allergy
to dust mites). These symptoms include sneezing, runny
or itchy nose, itchy palate, and itchy, red or watery eyes.
Desloratadine is also used to relieve the symptoms
associated with urticaria (a skin condition caused by an
allergy). These symptoms include itching and hives.
Relief of these symptoms lasts a full day and helps you
to resume your normal daily activities and sleep.

2. BEFORE YOU TAKE DESLORATADINE
Do not take Desloratadine
− if you are allergic (hypersensitive) to desloratadine,
to any of the other ingredients of Desloratadine or
to loratadine.
Desloratadine is indicated for adults and adolescents
(12 years of age and older).
Desloratadine contains soya oil. If you are allergic to
peanut or soya, do not use this medicinal product.
Take special care with Desloratadine
− if you have poor kidney function.
If this applies to you, or if you are not sure, please
check with your doctor before taking Desloratadine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.

There are no known interactions of Desloratadine with
other medicines.
Taking Desloratadine with food and drink
Desloratadine may be taken with or without a meal.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicine during pregnancy and breastfeeding.
If you are pregnant or nursing a baby, taking
Desloratadine is not recommended.
Driving and using machines
At the recommended dose, Desloratadine is not
expected to cause you to be drowsy or less alert.
However, very rarely some people experience
drowsiness, which may aﬀect their ability to drive or
use machines.

3. HOW TO TAKE DESLORATADINE
Always take Desloratadine exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
Adults and adolescents (12 years of age and older):
take one tablet once a day.
Swallow the tablet whole with water, with or
without food.
Regarding the duration of treatment, your physician will
determine the type of allergic rhinitis you are suﬀering
from and will determine for how long you should take
Desloratadine.
If your allergic rhinitis is intermittent (presence of
symptoms for less than 4 days per week or for less than
4 weeks), your physician will recommend you a
treatment schedule that will depend on the evaluation
of the history of your disease.
If your allergic rhinitis is persistent (presence of
symptoms for 4 days or more per week and for more
than 4 weeks), your physician may recommend you a
longer term treatment.
For urticaria, the duration of treatment may be variable
from patient to patient and therefore you should follow
the instructions of your physician.

Use in children
Desloratadine is not indicated for children.
Desloratadine is indicated for adults and adolescents
(12 years of age and older).

dispose of medicines no longer required. These
measures will help to protect the environment.

6. FURTHER INFORMATION

What Desloratadine contains
If you take more Desloratadine than you should
– The active substance is desloratadine 5mg
Take Desloratadine only as it is prescribed for you.
(as desloratadine hemisulphate).
No serious problems are expected with accidental
overdose. However, if you take more Desloratadine than – The other ingredients are:
you were told to, contact your doctor or pharmacist.
Tablet core: cellulose, microcrystalline, calcium
hydrogen phosphate dihydrate, maize starch,
If you forget to take Desloratadine
pregelatinised, silica, colloidal anhydrous,
If you forget to take your dose on time, take it as soon
magnesium stearate.
as possible, then go back to your regular dosing
Film-coating: poly(vinyl alcohol) (E1203),
schedule. Do not take a double dose to make up for a
titanium dioxide (E 171), talc (E 553b), lecithin
forgotten dose.
(soya) (E 322), quinoline yellow aluminium lake
If you stop taking Desloratadine
(E 104), xanthan gum (E 415), iron oxide yellow
(E 172), indigo carmine aluminium lake (E 132).
Do not stop the treatment. Contact your doctor or
pharmacist before stopping.
What Desloratadine looks like and
If you stop taking Desloratadine, your symptoms will
contents of the pack
come back.
Desloratadine 5mg ﬁlm-coated tablets are yellow,
If you have any further questions on the use of this
round, biconvex ﬁlm-coated tablets, of about 6mm
product, ask your doctor or pharmacist.
diameter, one side engraved with ‘R03’.
Desloratadine 5mg ﬁlm-coated tablets are packaged in
4. POSSIBLE SIDE EFFECTS
PVC/PE/PVDC//Al blisters. The blisters are packed
into cardboard cartons.
Like all medicines, Desloratadine can cause side
eﬀects, although not everybody gets them.
Pack sizes are:
7, 10, 20, 30, 50, 90, 100 ﬁlm-coated tablets
In clinical trials, in adults, side eﬀects were about the
same as with a dummy tablet (i.e. a tablet without
Not all pack sizes may be marketed.
containing the active substance). However, fatigue,
Marketing Authorisation Holder and Manufacturer
dry mouth and headache were reported more often
than with a dummy tablet. In adolescents, headache
Marketing Authorisation Holder:
was the most commonly reported side eﬀect.
Gedeon Richter Plc.
During the marketing of desloratadine, cases of severe Gyömrői út 19-21
allergic reactions (diﬃculty in breathing, wheezing,
H-1103 Budapest
itching, hives and swelling) and rash have been
Hungary
reported very rarely. Cases of palpitations, rapid
Manufacturer:
heartbeat, stomach pain, nausea (feeling sick),
Gedeon Richter Romania SA
vomiting, upset stomach, diarrhoea, dizziness,
99-105, Cuza Vodă Street
drowsiness, inability to sleep, muscle pain,
540306
Târgu-Mureş
hallucinations, seizures, restlessness with increased
Romania
body movement, liver inﬂammation and abnormal liver
Distributor:
function tests have also been reported very rarely.
Aspire
Pharma Ltd
If any of the side eﬀects gets serious, or if you notice
Bellamy House
any side eﬀects not listed in this leaﬂet, please tell
Winton Road
your doctor or pharmacist.
Petersﬁeld
Hampshire
5. HOW TO STORE DESLORATADINE
GU32 3HA
Keep out of the reach and sight of children.
United Kingdom
Do not use Desloratadine after the expiry date.
The expiry date refers to the last day of that month.
This leaﬂet was last approved in 09/2013
This medicinal product does not require any special
storage conditions.
Do not use Desloratadine if you notice any change in
the appearance of the tablets.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
1010173 P3.1

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.